Comment:

IHE has seen the need to support Serial Number on medication - stemming from the EU FMD and Serialization directives, and the US DSDCA. Like the work that has been done for UDI, this is needed, and should have a core basis. It is necessary that implementers adopt serial number in a consistent way, otherwise, if it is an extension, implementations may differ in form or content - for example some may interpret "identifier" as a serial number, others may resort to extension - this harms the intent of the regulations, which is safe and traceable distribution of meds.

Summary:

Gforge Item 13954 - support serial numbers on medication. - The actual resolution may not be the same as the IHE extension, but a core solution is sought to support US and EU regulatory requirements to preserve the safety of the supply and delivery of drugs.